The French National Agency for the Safety of Medicines and Health Products (ANSM) has published the opinion of the temporary specialized scientific committee (CSST) tasked with evaluating the place and use of textured breast implants in cosmetic and reconstructive surgery. Find the conclusions of the CSST "Public consultation on the place and use of textured breast implants in cosmetic and reconstructive surgery" below.
The placement of textured breast implants carries a number of known and documented risks, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In reconstructive surgery
In reconstructive surgery, the use of textured implants is not essential but remains indicated in a number of situations in which the implant's texture provides a proven benefit (in terms of anatomical shape, stability, tissue expansion and reduced risk of capsular contracture).
In cosmetic surgery
In cosmetic surgery, the use of textured implants is not essential but may remain one option among others in a number of situations in which the implant's texture provides a proven benefit (in terms of stability, tissue expansion and reduced risk of capsular contracture).
In the context of the ANSM's recommendation to preferentially use smooth implants, and given the doubts raised by healthcare professionals, the use of Allergan's Biocell texture should be prohibited. The greatest caution should be exercised with breast implants of equivalent texture and with polyurethane implants.
The committee does not, however, recommend preventive removal of these textured implants.
In the context of the ANSM's recommendation to preferentially use smooth implants, and given the doubts raised by healthcare professionals regarding macrotextured and polyurethane implants, limited and regulated conditions of use should be defined:
- Through a standardized texture classification, to be defined at the European level.
- Through rigorous and complete information for patients on these medical devices, whose use is not without consequence, on the alternatives that exist to textured breast implants, and on the annual follow-up (at minimum clinical and ultrasound) that their placement should involve.
- Through more systematic information for other healthcare professionals who may follow up with patients who have textured breast implants regarding the risks associated with these devices, including BIA-ALCL (particular attention should be paid to significant peri-prosthetic effusion, breast redness, increase in volume, a palpable mass or lymph nodes, ulceration, or general deterioration).
- Through greater transparency and a guarantee provided by manufacturers regarding the quality and safety of their medical devices.
The national breast implant registry, whose creation has just been approved, should be established promptly.
> Find the conclusions on the ANSM website
> Download the CSST opinion summary (pdf)
> Learn more about breast augmentation with implants
> Which breast implants does Dr Kron use? Advantages of Motiva implants
Update of 03/22/2019: Information notice
Based on the opinion of the temporary specialized scientific committee (CSST), the ANSM announced that it would make a decision on the use of textured-shell breast implants in cosmetic and reconstructive surgery.
No decision has been made by the ANSM at this stage. The ANSM will make its decision public shortly, in accordance with its commitments.
Therefore, any information to the contrary that may circulate should be considered false and not validated by the ANSM.
In this context, the ANSM reminds women that if in doubt, they should consult their surgeon or a healthcare professional.
Learn more:
> The information notice on the ANSM website
> Download the expert opinion (pdf)
> BIA-ALCL: the French National Cancer Institute publishes updated guidance
